Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay

Completed

Conditions studied: Pregnancy, GBS

In brief

The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks gestation.

Key facts

Study ID

NCT02497430

Run by

Luminex Corporation

People needed

918

Starts

2016-03-01

Expected to finish

2016-08-01

Last updated by the study team

2016-09-15

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• An exemption from the requirement for Informed Consent has been granted by the site IRB to include the left-over patient specimens in the study.
• Demographic information, including age, geographic location, and number of gestation weeks, is included with the specimen.
• The specimen is from a female patient who is at 35 - 37 weeks gestation.
• The specimen was collected in unexpired liquid Transport Media (e.g., Liquid Stuart or Liquid Amies).
• Enrichment in Lim broth was grown for ≥18 hrs to ≤24 hrs.
• The specimen is received in good condition (no leakage or drying of the specimen) and was accepted for testing by the site in accordance with established laboratory procedures.
• The volume of the patient specimen after enrichment is sufficient (≥ 1.75mL) for completion of the study.

You may not qualify if…

• The specimen was collected at a site which is not covered under the study IRB.
• The specimen is from a patient for whom demographic data - age, geographic location and/or gestation weeks cannot be obtained.
• The specimen was not properly collected, identified, transported, processed or stored according to the instructions provided by the Sponsor.
• The specimen was enriched in Lim broth for <18 hrs or >24 hrs.
• A swab specimen that cannot be placed in Lim broth within 4 days of collection.
• Inconclusive latex agglutination results - weak agglutination, agglutination that occurs in more than one latex reagent or the results are otherwise considered inconclusive based on established laboratory procedures or the instructions included with the latex agglutination test kit.
• Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.

Where it is running

• Sacred Heart Health System — Pensacola, Florida, United States
• Detroit Medical Center University Laboratories — Detroit, Michigan, United States
• TriCore Reference Laboratories — Albuquerque, New Mexico, United States
• Geisinger Medical Laboratories — Danville, Pennsylvania, United States
• Baylor Scott & White — Temple, Texas, United States

Full record on ClinicalTrials.gov

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